Heparin News Archive
CDC Identifies Cause of Heparin-Related Reactions
-PharmTech
12/12/2008- A Centers for Disease Control and Prevention (CDC) study confirmed that severe adverse reactions reported in the fall and winter of 2007 resulted from heparin contaminated with oversulfated chondroitin sulfate (OSCS). The study, “Outbreak of Adverse Reactions Associated with Contaminated Heparin,” was published on The New England Journal of Medicine’s website on Dec. 3, 2008. More>>>
FDA Issues Warning List of Heparin Products
-DOTmed
12/6/2008- Over the past year, Heparin, a widely used injectable anticoagulant, has come under intense scrutiny from consumer protection groups and the Food and Drug Administration. In December 2007, the FDA recalled a shipment of heparin because of a growth of Serratia marcescens in several unopened syringes of this product. Serratia marcescens is a bacterium that can lead to life-threatening injuries and/or death. More>>>
FDA Safety Changes: Heparin Sodium Injection, Photofrin, Noroxin
-Medscape
11/28/2008- The US Food and Drug Administration (FDA) has approved safety labeling revisions to warn of the risk for medication errors and heparin-induced thrombocytopenia in patients receiving heparin sodium injection, an increased duration of photosensitivity in patients with renal or hepatic impairment receiving porfimer sodium injection, and the risk for rare but fatal reactions in patients receiving norfloxacin and other quinolone antibiotics. More>>>
FDA Seizes Contaminated Heparin from a Cincinnati Manufacturer
- FDA News
11/06/2008 - As part of the U.S. Food and Drug Administration's ongoing efforts to ensure that heparin for patients remains safe, the government today seized 11 lots of heparin from Celsus Laboratories Inc. in Cincinnati, Ohio. More>>>
"We Lost our Mother because of Heparin"
-LawyersandSettlements
08/17/2008- Santa Barbara, CA: "My mum was hospitalized on several occasions and I know she was given Heparin every time," says Antoinette. "According to her physician, Heparin was also given to her so she wouldn't get blood clots during dialysis." More>>>
Another Sufferer from Contaminated Heparin?
-Lawyers and Settlements
07/24/2008 - Len was scheduled for minor surgery and complained to the doctor that he had some pain in his left calf—they found a blood clot. He was admitted to hospital in August 2006 and was given an IV with Heparin. Instead of recovering, Len says his health deteriorated. More>>>
Heparin May Have Caused Father's Death
-Lawyers and Settlements
06/24/2008 - Raymond S is one of a growing number of people trying to determine if a loved one was given Heparin during surgery. Raymond says he believes that, based on his father's sudden health decline and low blood pressure, there is a good chance he was given the drug. More>>>
FDA: Allergic reactions to heparin linked to 149 deaths
-Boston Globe
06/18/2008 - The FDA posted on its Web site that 149 deaths in the U.S. have been linked to allergic reactions to the blood thinner heparin; the count is up from 81 reported in April. More>>>
Heparin: "We Lost My Dad"
-Lawyers and Settlements
06/16/2008 - More people are learning that Heparin may have caused their loved one's death. Kelly C. says her father was given Heparin right before he fell into a coma from which he never regained consciousness. She believes that Heparin may have been the cause of his coma and, ultimately, his death. More>>>
FDA: Tainted heparin still out there
-Renal Business Today
06/11/2008 - Injectable heparin products and heparin flush solutions that may be contaminated with oversulfated chondroitin sulfate (OSCS) were found in medical care facilities in one state since the heparin recall, according to the U.S. Food and Drug Administration. More>>>
Heparin in Medical Devices Linked to 11 U.S. Deaths
-Bloomberg
06/05/2008 - Eleven deaths and 86 cases of harmful side effects have been linked to use of medical devices containing the blood thinner heparin, U.S. regulators said. More>>>
Tainted Drug Imports Set Off Warnings, Not FDA Action
-Bloomberg
05/30/2008 - Two Americans died and 15 suffered seizures. The suspected cause: The epilepsy medicine they depended on stopped working because of a counterfeit ingredient from overseas. More>>>
Unraveling the Mystery of Heparin-Related Death
-Lawyers and Settlements
05/29/2008 - Researchers at the Massachusetts Institute of Technology (MIT) have discovered just why tainted heparin is so deadly. The contaminant, oversulfated chondroitin sulfate – OSCS, causes allergic reactions by activating two inflammatory pathways. More>>>
FDA Issues Another Heparin Warning, Faces More Backlash in Congress
-NewsInferno.com
05/13/2008- Some medical facilities still have recalled heparin in their inventories, prompting the Food & Drug Administration (FDA) to issue yet another warning about the defective drug. More>>>
Medtronic Issues Precautionary Recall of Heparin-Coated Products
-FDA News
05/13/2008 - Medtronic is recalling certain heparin-coated disposable products used during cardiopulmonary bypass for heart surgeries. More>>>
Heparin Contamination May Have Been Deliberate, F.D.A. Says
-NY Times
04/30/2008 - Federal drug regulators believe that a contaminant detected in a crucial blood thinner that has caused 81 deaths was added deliberately, something the Food and Drug Administration has only hinted at previously. More>>>
Congressman: ‘Citizens Can No Longer Trust’ FDA
-Wall Street Journal
04/30/2008 - The FDA got another tongue lashing from Rep. John Dingell yesterday, who seems frustrated that the agency isn’t clamoring for more money to inspect foreign manufacturing plants. More>>>
Baxter CEO: Heparin contamination was deliberate
-Reuters
04/29/2008 - The contamination of Baxter International Inc's blood-thinner heparin appears to have been deliberate, the company's chief executive said in testimony prepared for a congressional hearing on Tuesday. More>>>
Families, CEOs to testify on tainted heparin in US
-Reuters
04/29/2008 - People who lost relatives to deadly reactions from the blood-thinner heparin are set to testify on Tuesday before U.S. lawmakers probing contamination of the drug made with raw ingredients imported from China. More>>>
The Frightening Heparin Case
-NY Times
04/28/2008 - The story of a deadly, contaminated blood thinner has laid bare serious deficiencies in the regulatory oversight of drugs imported from China and other developing countries. More>>>
Alert issued over heparin injection impurity
-Nursing Times
04/25/2008 -- Nurses are being warned to look out for adverse drug reactions (ADRs) after some batches of a heparin injection drug were found to contain impurities. More>>>
Researchers Agree With FDA, Confirm Heparin Contaminant
- dbtechno.com
04/25/2008 -- Researchers in the U.S. have come out and stated that they have found a chemical contaminant in the blood-thinner heparin. The contaminant found in the heparin, which came from China, has been proven to be potentially deadly. More>>>
Impurities found in Sanofi heparin product
-Fierce Pharma
04/25/2008 -- While heparin maker Baxter mulls whether to re-enter the market for that blood thinner, Sanofi-Aventis is announcing that small amounts of an impurity have been found in batches of its heparin injection Lovenox. More>>>
How Tainted Heparin Slipped Through U.S. Safety Net
- MedPage Today
04/25/2008 -- Researchers here revealed today how the adulterated heparin from China evaded detection at the U.S. border and how it killed scores of patients. More>>>
Bayer CEO says faces 78 Trasylol lawsuits in U.S.
-Reuters
04/25/2008 - Germany's Bayer AG is facing 78 lawsuits in the United States linked to its Trasylol drug used to stem bleeding during open heart surgery, its chief executive said on Friday. More>>>
FDA: Contaminated Heparin Linked To Allergic Reaction
-CNN
04/24/2008- WASHINGTON -(Dow Jones)- A top Food and Drug Administration official said Monday the agency has found a link between contaminated lots of Baxter International Inc.'s (BAX) blood-thinner heparin and hundreds of allergic reactions and dozens of deaths. More>>>
Contaminated blood thinner heparin called a worldwide problem
-LA TIMES
04/24/2008- WASHINGTON -- A contaminated blood thinner from China suspected in dozens of U.S. deaths has become a worldwide public health problem, with 10 other countries detecting the often-toxic ingredient, federal investigators said Monday. More>>>
House Panel Criticizes F.D.A. Role in Drug Cases
-NY Times
04/23/2008 -- House members chastised the Food and Drug Administration on Tuesday for not doing more inspections of foreign drug manufacturers in the wake of a litany of problems with the blood thinner heparin and other products. More>>>
FDA IDs Link Between Heparin Contaminant, Adverse Reactions
-FDA News
04/23/2008 -- FDA data show a “solid mechanistic link” between a heparin-like contaminant originating in China and serious adverse events and deaths, CDER Director Janet Woodcock said. More>>>
FDA commissioner grilled on drug oversight lapses
-Chicago Tribune
04/23/2008 -- With dozens of people dead after receiving infusions of the contaminated blood thinner heparin, the head of the Food and Drug Administration faced withering scrutiny from a congressional subcommittee. More>>>
What You Need To Know About Heparin
-Campus Progress
04/23/2008 -- It’s been linked to the death of dozens, and it’s leading to a clash between researchers and policy makers in America and China. But… what is it? More>>>
U.S. Identifies Tainted Heparin in 11 Countries
-NY Times
04/22/2008 -- A contaminated blood thinner from China has been found in drug supplies in 11 countries, and federal officials said Monday they had discovered a clear link between the contaminant and severe reactions now associated with 81 deaths in the United States. More>>>
Death Toll Due to Tainted Heparin in US Rises to 81
-OpEd News
04/22/2008 -- Federal officials in the US now say that the death toll due to adverse reactions to contaminated heparin coming from China has risen to 81, whereas Chinese officials dispute that any deaths were caused by the contaminant. More>>>
China Says Contaminant Didn't Cause Heparin Reactions
-Bloomberg
04/21/2008 -- A contaminant in the blood-thinner heparin that was identified last month by U.S. regulators wasn't responsible for causing allergic reactions and deaths, a Chinese regulator said. More>>>
China says chemical not source of heparin woes
-Reuters
04/21/2008 -- A Chinese investigation concluded that a contaminant found in the blood thinner heparin was not the cause of deaths and allergic reactions related to the drug in the United States, a Chinese health official said on Monday. More>>>
Four More Contaminated Heparin Lawsuits being Filed in Toledo
-LawyersandSettlements
04/20/2008 -- Four more people are filing lawsuits in the Toledo, Ohio area against Baxter Healthcare, the maker of the drug heparin, stating that the drug was contaminated when it was given to their family members. More>>>
Tainted Heparin Discussed By U.S., Other Countries, FDA Says
- Bloomberg
04/20/2008- The U.S. hosted a meeting of international regulators that ended today on the blood-thinner heparin, a drug linked to allergic reactions and deaths. More>>>
FDA fears heparin tainted on purpose
-Boston Globe
04/16/2008 - US regulators suspect that Baxter International Inc.'s blood thinner heparin, linked to deaths and allergic reactions, was intentionally contaminated to increase profit. More>>>
Heparin death tally worsens; FDA issues device warning
-InPharmaTechnologists
04/14/2008 - The number of people whose deaths are associated with an allergic reaction to heparin has shot up as the US Food and Drug Administration (FDA) has updated its tally. More>>>
FDA: Heparin Linked To 62 Deaths
-AHN
04/11/2008 - The Food and Drug Administration has linked 62 deaths to heparin, a blood thinner drug manufactured in China. More>>>
Baxter's Heparin Killed Mother and Son, Family Says
-Bloomberg
04/10/2008 - Bonnie Hubley, 65, died in December. A month later, so did her 47-year-old son.
Both suffered from an inherited kidney disease, and relatives at first assumed they died from years of health complications. The family also suspected that Randy, who lived three miles from his parents in Toledo, Ohio, was so devastated by his mother's death that he lost the will to survive. More>>>
Suit alleges Baxter's heparin killed wife
-Chicago Tribune
04/03/2008 - Baxter International Inc. faces a growing number of lawsuits from families who blame the company's blood-thinning drug heparin for deaths of loved ones. Heparin was used by millions of people to prevent blood clots during dialysis and other medical procedures. More>>>
Editorial: We can't afford FDA bungling on pharmaceuticals
-Mercury News
04/03/2008 - The Food and Drug Administration should be embarrassed by its lack of attention to the ingredients in prescription drugs. More>>>
Covidien-brand heparin syringes recalled
-UPI
04/02/2008 - The U.S. Food and Drug Administration announced the recall of 32 lots of Covidien-brand pre-filled heparin syringes because of possible contamination. More>>>
Officials Question Safety Of Overseas Drug Manufacturers
-NBC News
04/02/2008 - Heparin is a drug used - safely - by millions of Americans to prevent blood clots. It's been around for decades. But recently, a bad batch of Heparin made hundreds of people sick and killed 19 of them. More>>>
Pre-filled syringes containing Heparin recalled
-ABC News
04/02/2008 - Covidien is voluntarily recalling pre-filled syringes after being notified of a nation-wide recall of Heparin Sodium USP active pharmaceutical ingredient. More>>>
Bill seeks overseas oversight for FDA
-Politico, DC
04/01/2008 - Concerns were raised over the blood thinning drug Heparin after the Food and Drug Administration announced that it caused an allergic reaction in more than 700 people, some of whom died. More>>>
Post-heparin, no oversight excuses
-FiercePharma, DC
04/01/2008 - What's the long-term impact of the heparin scare? It's shattered U.S. claims of "it can't happen here," for one thing. When Chinese-made cold meds killed 120 in Panama over a year ago, Americans thought the same thing couldn't happen here. More>>>
Bad drugs at a pharmacy near you
-Washington Times
03/31/2008 - The FDA believes it has discovered the contaminant in the blood-thinning drug heparin that has caused hundreds of allergic reactions and 19 deaths. More>>>
Illinois senator concerned about Heparin
-ABC News
03/31/2008 - Concerns were raised over the blood thinning drug Heparin after the Food and Drug Administration announced that it caused an allergic reaction in more than 700 people, some of whom died. More>>>
Heparin Scare: criminal corruption, not FDA carelessness
-Blogger News
03/30/2008 - The NYTimes has a nice “summary” article on the heparin scare today. They do a nice job, but they seem to assume that the episode is an accident, so the article it points to the FDA for failing to regulate the drug manufacturing process. More>>>
France, Italy and Denmark Join Heparin Recall
-AHN
03/27/2008 - Few days ago, France, Italy and Denmark joined the increasing numbers of nations recalling heparin, the popular blood-thinning medication that in recent weeks was reported to contain contaminated raw ingredients, leading to hundreds of allergic reactions and 19 deaths in the U.S. More>>>
Heparin recall spreads in Europe
-FiercePharma
03/26/2008 - In what seems to be a daily occurrence, more countries are announcing heparin recalls. France, Italy, and Denmark recalled the blood thinner or its ingredients. More>>>
China Requires Heparin Makers to Get Raw Material From Registered Suppliers
-FDA News
03/25/2008 - China’s Ministry of Commerce is requiring local heparin makers to increase testing of raw materials, improve postsale tracking and ensure their raw material comes from registered suppliers. More>>>
Batches of Heparin Are Recalled In France,
Italy and Denmark
-Wall Street Journal
03/25/2008 - Batches of the blood-thinning drug heparin, and some ingredients used to make it, are being recalled in France, Italy and Denmark because they are contaminated or suspected of being contaminated, a spokesman for the European Medicines Agency, or EMEA, said Tuesday. More>>>
Learning from the heparin fiasco
-LA Times
03/25/2008 - Just two years ago, the U.S. government was confiscating Canadian pharmaceuticals that had been ordered by mail and online by American patients looking to save money. The stated rationale was that consumers had to be protected from drugs that might fail to meet this country's manufacturing standards. More>>>
Heparin recall widens in US
-Outsourcing-pharma.com
03/25/2008 - The heparin recall has widened after a lot of heparin sodium USP active pharmaceutical ingredient (API) produced by Scientific Protein Laboratories (SPL) was found to contain a heparin-like contaminant. More>>>
FDA Identifies Contaminant in Heparin API, Investigation Shifts to Source
-FDA News
03/21/2008 - The impurity detected in the active pharmaceutical ingredient (API) used in Baxter’s recalled heparin products is a highly sulfated form of chondroitin sulfate, a chemical cheaper to manufacture than bulk heparin sodium, according to the FDA. More>>>
China clamps down on production of Heparin
-Baltimore Sun
03/21/2008 - China announced today it is clamping down on production of Heparin in the latest sign that suppliers there were to blame for contamination of the blood-thinning drug that has killed as many as 19 Americans. More>>>
China Confirms It’s the Source of Heparin Contaminant
-Wall Street Journal
03/20/2008 - China’s State Food and Drug Agency has confirmed that the contaminant in Baxter’s heparin was introduced in China, Bloomberg reports. More>>>
Heparin Discovery May Point to Chinese Counterfeiting
-NY Times
03/20/2008 - Federal drug regulators, in announcing Wednesday that the mystery contaminant in heparin was an inexpensive, unapproved ingredient altered to mimic the real thing, moved closer to concluding that Americans might be the latest victims of lethal Chinese drug counterfeiting. More>>>
Heparin contaminant identified
-LA Times
03/20/2008 - A compound related to a common nutritional supplement has been identified as the contaminant in a blood-thinning drug imported from China that sickened hundreds of frail patients in the U.S. and is suspected in a number of deaths, federal officials said Wednesday. More>>>
Handling Heparin
-PharmExec.com
03/19/2008 - FDA isn't yet ready to say that it knows why US patients died after taking the blood thinner heparin, but it has announced what sounds like a strategy for testing and controlling import of the drug in a series of cryptic poster-like documents. More>>>
Contaminant found in heparin
-Yahoo News
03/19/2008 - U.S. health officials have identified a contaminant in batches of the blood thinner heparin associated with 19 deaths and are trying to determine how the chemical got into the drug. More>>>
Scientists Near Source of Altered Heparin
-NY Times
03/19/2008 - Scientists investigating a mystery contaminant in the blood thinner heparin are closing in on what they believe is a counterfeit substance, most likely made in China from animal cartilage, that was chemically altered to act like the real drug. More>>>
Chinese Heparin Was Probably Cut with Counterfeit Substance
-eNews 2.0
03/19/2008 - Federal drug regulators announced that the blood-thinning drug Heparin that had been linked to several deaths and hundreds of allergic reactions was contaminated with a fake ingredient got there by mistake or by fraud. More>>>
FDA plans wider foreign inspection approach
-Food Production Daily
03/18/2008 - The US Food and Drug administration (FDA) is seeking permission from the Chinese government to install eight full time FDA officials in the country, as part of plans to improve monitoring of exported food manufacturing across the globe. More>>>
FDA Instituting Testing Program for Imported Heparin
-FDA News
03/18/2008 - As regulators worldwide are increasingly concerned that the supply of heparin active pharmaceutical ingredient (API) might be contaminated, the FDA is implementing a program to test all heparin entering the U.S. More>>>
FDA moves to allay drug-import fears
-FiercePharma
03/17/2008 - Just as the Fed is scrambling for new initiatives to shore up the U.S. financial system, the FDA is hustling up new programs designed to shore up confidence in drug safety--and in its own ability to ensure it. More>>>
Germany Asks Drug Firms to Test Heparin
-Wall Street Journal
03/12/2008 - Germany's medical regulator has asked companies selling the blood thinner heparin in Germany to test all batches of their product for contamination, the regulator said. More>>>
China-made heparin scare spreads beyond US
-Outsourcing-Pharma.com
03/11/2008 - The made-in-China heparin scare has now spread beyond the US, with Germany and Japan both recalling the drug. More>>>
How Heparin Maker in China Tackles Risks
-Wall Street Journal
03/10/2008 - Inside Shenzhen Hepalink Pharmaceutical Co.'s high-tech factory in this southern China boomtown, workers in blue protective suits, surgical masks and gloves produce the active ingredient for heparin, the widely used blood-thinning medication. More>>>
CHUCK RIPS FDA OVER CHINA RISK
-New York Post
03/10/2008 - An anemic Food and Drug Administration needs a $500 million infusion to increase its overseas inspections after a violations-riddled Chinese factory was linked to the contaminated blood thinner Heparin, which has killed 19 people in the United States, Sen. Chuck Schumer charged yesterday. More>>>
China Washes Hands on Heparin Purity
-Wall Street Journal
02/27/2008 - If the U.S. is concerned about the quality of raw heparin imported from China, the Americans need to make sure the proper controls are in place, China’s State Food and Drug Administration said today. More>>>
China Has No Fault for Bad Quality Heparin
-enews2.0
02/27/2008 - Commenting on an investigation into the recalled drug heparin, China’s State Food and Drug Administration declared Wednesday that it strictly controlled chemicals used in pharmaceuticals, but the importing countries should be the ones responsible for ensuring the imported products are safe. More>>>
Baxter Suspends Multidose Heparin Production After Allergic Reactions
-FDA News
02/13/2008 - Baxter and the FDA are investigating manufacturing facilities and processes for multidose Heparin after a spike in serious adverse events associated with it caused the company to suspend production of multidose vials of the drug. More>>>
If you or a loved one have experienced Heparin Sodium Injection side effects you may be entitled to compensation. Contact the Heparin attorneys of Ennis & Ennis today for a free confidential case evaluation. Our on staff nurse and lawyers are standing by to answer any questions you may have regarding Heparin side effects, a possible Heparin class action lawsuit, or any other type of Heparin Sodium Injection litigation.
